2007'02.01.Thu
TAXUS(R) Liberte(TM) Stent System Receives European Approval for Three Complex Coronary Procedures

May 16, 2006
- Boston Scientific's Second-Generation Stent System
Now Approved for
Treatment of Acute Mycocardial Infarction, Total
Occlusions and In-Stent
Restenosis
- Large Vessel TAXUS Liberte Stent Also Receives CE
Mark
NATICK, Mass., and PARIS, May 16 /Xinhua-PRNewswire/ --
Boston Scientific Corporation (NYSE: BSX) announced today
that it has received indication extensions to the European
CE mark for its TAXUS(R) Liberte(TM) paclitaxel-eluting
coronary stent system for use in some of the most
challenging coronary procedures.
The new labeling reflects a review of TAXUS clinical
data by the European regulatory agency. In addition to its
existing indication for the treatment of de-novo lesions in
native coronary arteries, the TAXUS Liberte stent system is
now indicated in Europe for the treatment of restenotic
lesions (in-stent restenosis, or ISR) and total occlusions
(TO) in patients with coronary artery disease, including
acute myocardial infarction (AMI). These three new
indications account for more than 20 percent of all
coronary interventions.
The TAXUS Liberte stent system is now the only
drug-eluting stent system with these new indications for
use in Europe.
This revised labeling follows the excellent clinical
outcomes the TAXUS stent system has shown in the treatment
of complex lesions in recent clinical trials and
registries, including the TAXUS V ISR trial and the
MILESTONE II, WISDOM, ARRIVE, and OLYMPIA registries.
In addition to the three new indications, the large
vessel diameter TAXUS Liberte stent also received the CE
mark. This stent uses a modified cell design intended for
drug delivery in larger vessels, and will be available in a
4.0 mm diameter and seven different lengths.
"The European approval for new indications
recognizes the strong long-term performance of the TAXUS
stent system across complex patients and lesions,"
said Jeff Goodman, President of Boston Scientific
International. "It allows physicians to treat
difficult cases of coronary artery disease with the most
advanced technology."
Boston Scientific is a worldwide developer,
manufacturer and marketer of medical devices whose products
are used in a broad range of interventional medical
specialties. For more information, please visit:
http://www.bostonscientific.com .
This press release contains forward-looking statements.
Boston Scientific wishes to caution the reader of this press
release that actual results may differ from those discussed
in the forward-looking statements and may be adversely
affected by, among other things, risks associated with new
product development and commercialization, clinical trials,
intellectual property, regulatory approvals, competitive
offerings, integration of acquired companies, Boston
Scientific's overall business strategy, and other factors
described in Boston Scientific's filings with the
Securities and Exchange Commission.
For more information, please contact:
Geraldine Varoqui,
Boston Scientific PR Manager International
Tel: +49-2102-489-461
Email: varoquig@bsci.com
Maren Koban,
BSC press office
Tel: +44-20-7973-4497
Email: mkoban@hillandknowlton.com
SOURCE Boston Scientific Corporation
PR
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